UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057469 |
|---|---|
| Receipt number | R000065665 |
| Scientific Title | Observational study of the difference in cuff pressure increase due to air injection during tracheal intubation and esophageal intubation |
| Date of disclosure of the study information | 2025/05/01 |
| Last modified on | 2025/03/31 21:36:09 |
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Basic information
Public title
Observational study of the difference in cuff pressure increase due to air injection during tracheal intubation and esophageal intubation
Acronym
Differences in cuff pressure rise between endotracheal intubation and esophageal intubation
Scientific Title
Observational study of the difference in cuff pressure increase due to air injection during tracheal intubation and esophageal intubation
Scientific Title:Acronym
Differences in cuff pressure rise between endotracheal intubation and esophageal intubation
Region
| Japan |
Condition
Condition
Patient undergoing oral tracheal intubation
Classification by specialty
| Anesthesiology | Emergency medicine | Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Observe the difference in pressure when air is injected into the cuff during tracheal intubation and esophageal intubation.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Pressure when inflating the cuff during tracheal intubation and esophageal intubation
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients scheduled for surgery under general anesthesia
Key exclusion criteria
Patients who are expected to have difficulty breathing through a mask (e.g. obese patients with a BMI of 35 or more)
Patients who cannot tolerate hypoxia (ischemic heart disease, carotid artery stenosis, etc.)
Other patients who the principal investigator deems unsuitable as test subjects
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Shinji |
| Middle name | |
| Last name | Takahashi |
Organization
Juntendo University Hospital Urayasu
Division name
Anesthesiology
Zip code
2790021
Address
2-1-1 Tomioka, Urayasu City, Chiba Prefecture
TEL
047-353-3111
y.hiramoto.sf@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | Yoshiyuki |
| Middle name | |
| Last name | Hiramoto |
Organization
Juntendo University Hospital Urayasu
Division name
Anesthesiology
Zip code
2790021
Address
2-1-1 Tomioka, Urayasu City, Chiba Prefecture
TEL
047-353-3111
Homepage URL
y.hiramoto.sf@juntendo.ac.jp
Sponsor or person
Institute
juntendo university
Institute
Department
Personal name
Funding Source
Organization
No
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
juntendo Clinical Research and Trial Center
Address
3-1-3 Hongo, Bunkyo-ku, Tokyo
Tel
03-3813-3111
jcrtc_operation@juntendo.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 05 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2025 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2030 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Observational study
Management information
Registered date
| 2025 | Year | 03 | Month | 31 | Day |
Last modified on
| 2025 | Year | 03 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065665
